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Start Preamble
AGENCY:
Drug Enforcement Administration (DEA), Justice.
ACTION:
Notice of proposed revised 2009 aggregate production quotas.
SUMMARY:
This notice proposes revised 2009 aggregate production quotas for Start Printed Page 36512controlled substances in schedules I and II of the Controlled Substances Act (CSA).
DATES:
Written comments must be postmarked, and electronic comments must be sent, on or before August 24, 2009.
ADDRESSES:
To ensure proper handling of comments, please reference “Docket No. DEA-317R” on all written and electronic correspondence. Written comments should be sent to the DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be directly sent to DEA electronically by sending an electronic message to dea.diversion.policy@usdoj.gov. An electronic copy of this document is also available at the http://www.regulations.gov Web site. However, persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, or by telephone at (202) 307-7183.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. The Administrator in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
On November 7, 2008, a notice of proposed 2009 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (73 FR 66256). This notice stipulated that the DEA would adjust the quotas in 2009 as provided for in 21 CFR part 1303.
The proposed revised 2009 aggregate production quotas represent those quantities of controlled substances in schedules I and II that may be produced in the United States in 2009 to provide adequate supplies of each substance for: The estimated medical, scientific, research and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes.
The proposed revisions are based on a review of 2008 year-end inventories, 2008 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information available to the DEA.
Therefore, under the authority vested in the Attorney General by Section 306 of the CSA (21 U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes the following revised 2009 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base:
Basic class—schedule I Previously established initial 2009 quotas Proposed revised 2009 quotas 2,5-Dimethoxyamphetamine 2 g 2 g 2,5-Dimethoxy-4-ethylamphetamine (DOET) 2 g 2 g 3-Methylfentanyl 2 g 2 g 3-Methylthiofentanyl 2 g 2 g 3,4-Methylenedioxyamphetamine (MDA) 25 g 25 g 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 10 g 10 g 3,4-Methylenedioxymethamphetamine (MDMA) 20 g 20 g 3,4,5-Trimethoxyamphetamine 2 g 2 g 4-Bromo-2,5-dimethoxyamphetamine (DOB) 2 g 2 g 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 2 g 2 g 4-Methoxyamphetamine 27 g 27 g 4-Methylaminorex 2 g 2 g 4-Methyl-2,5-dimethoxyamphetamine (DOM) 2 g 2 g 5-Methoxy-3,4-methylenedioxyamphetamine 2 g 2 g 5-Methoxy-N,N-diisopropyltryptamine 5 g 5 g Acetyl-alpha-methylfentanyl 2 g 2 g Acetyldihydrocodeine 2 g 2 g Acetylmethadol 2 g 2 g Allylprodine 2 g 2 g Alphacetylmethadol 2 g 2 g Alpha-ethyltryptamine 2 g 2 g Alphameprodine 2 g 2 g Alphamethadol 2 g 2 g Alpha-methylfentanyl 2 g 2 g Alpha-methylthiofentanyl 2 g 2 g Aminorex 2 g 2 g Benzylmorphine 2 g 2 g Betacetylmethadol 2 g 2 g Beta-hydroxy-3-methylfentanyl 2 g 2 g Beta-hydroxyfentanyl 2 g 2 g Betameprodine 2 g 2 g Betamethadol 2 g 2 g Betaprodine 2 g 2 g Bufotenine 3 g 3 g Cathinone 3 g 3 g Codeine-N-oxide 602 g 602 g Start Printed Page 36513 Diethyltryptamine 2 g 2 g Difenoxin 3,000 g 3,000 g Dihydromorphine 2,549,000 g 2,549,000 g Dimethyltryptamine 3 g 3 g Gamma-hydroxybutyric acid 24,200,00 g 24,200,000 g Heroin 20 g 20 g Hydromorphinol 2 g 2 g Hydroxypethidine 2 g 2 g Ibogaine 1 g 1 g Lysergic acid diethylamide (LSD) 10 g 10 g Marihuana 4,500,000 g 4,500,000 g Mescaline 7 g 7 g Methaqualone 5 g 5 g Methcathinone 4 g 4 g Methyldihydromorphine 2 g 2 g Morphine-N-oxide 605 g 605 g N-Benzylpiperazine 2 g 2 g N,N-Dimethylamphetamine 7 g 7 g N-Ethylamphetamine 2 g 2 g N-Hydroxy-3,4-methylenedioxyamphetamine 2 g 2 g Noracymethadol 2 g 2 g Norlevorphanol 52 g 52 g Normethadone 2 g 2 g Normorphine 16 g 16 g Para-fluorofentanyl 2 g 2 g Phenomorphan 2 g 2 g Pholcodine 2 g 2 g Psilocybin 7 g 7 g Psilocyn 7 g 7 g Tetrahydrocannabinols 312,500 g 312,500 g Thiofentanyl 2 g 2 g Trimeperidine 2 g 2 g Basic class—schedule II Previously established initial 2009 quotas Proposed revised 2009 quotas 1-Phenylcyclohexylamine 2 g 2 g 1-Piperdinocyclohexanecarbonitrile 2 g 2 g Alfentanil 8,000 g 8,000 g Alphaprodine 2 g 2 g Amobarbital 3 g 3 g Amphetamine (for sale) 17,000,000 g 17,000,000 g Amphetamine (for conversion) 5,000,000 g 5,000,000 g Cocaine 247,000 g 247,000 g Codeine (for sale) 39,605,000 g 39,605,000 g Codeine (for conversion) 65,000,000 g 65,000,000 g Dextropropoxyphene 106,000,000 g 106,000,000 g Dihydrocodeine 1,200,000 g 1,200,000 g Diphenoxylate 947,000 g 947,000 g Ecgonine 83,000 g 83,000 g Ethylmorphine 2 g 2 g Fentanyl 1,428,000 g 1,428,000 g Glutethimide 2 g 2 g Hydrocodone (for sale) 55,000,000 g 55,000,000 g Hydromorphone 3,300,000 g 3,300,000 g Isomethadone 2 g 2 g Levo-alphacetylmethadol (LAAM) 3 g 3 g Levomethorphan 5 g 5 g Levorphanol 10,000 g 10,000 g Lisdexamfetamine 6,200,000 g 6,200,000 g Meperidine 8,600,000 g 8,600,000 g Meperidine Intermediate-A 3 g 3 g Meperidine Intermediate-B 7 g 7 g Meperidine Intermediate-C 3 g 3 g Metazocine 1 g 1 g Methadone (for sale) 25,000,000 g 25,000,000 g Methadone Intermediate 26,000,000 g 26,000,000 g Methamphetamine 3,130,000 g 3,130,000 g Start Printed Page 36514 [680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,405,000 grams for methamphetamine mostly for conversion to a schedule III product; and 45,000 grams for methamphetamine (for sale)] Methylphenidate 50,000,000 g 50,000,000 g Morphine (for sale) 35,000,000 g 35,000,000 g Morphine (for conversion) 100,000,000 g 100,000,000 g Nabilone 9,002 g 9,002 g Noroxymorphone (for sale) 10,000 g 10,000 g Noroxymorphone (for conversion) 9,000,000 g 9,000,000 g Opium (powder) 1,050,000 g 230,000 g Opium (tincture) 230,000 g 1,050,000 g Oripavine 15,000,000 g 15,000,000 g Oxycodone (for sale) 77,560,000 g 77,560,000 g Oxycodone (for conversion) 3,400,000 g 3,400,000 g Oxymorphone 2,000,000 g 2,000,000 g Oxymorphone (for conversion) 12,000,000 g 12,000,000 g Pentobarbital 28,000,000 g 28,000,000 g Phenazocine 1 g 1 g Phencyclidine 20 g 20 g Phenmetrazine 2 g 2 g Phenylacetone 1 g 1 g Racemethorphan 2 g 2 g Remifentanil 500 g 500 g Secobarbital 67,000 g 67,000 g Sufentanil 10,300 g 10,300 g Tapentadol 1 0 g 519,000 g Thebaine 126,000,000 g 126,000,000 g 1 Tapentadol was placed in schedule II of the Controlled Substances Act by a final order published by the Drug Enforcement Administration on May 21, 2009 (74 FR 23790). The Deputy Administrator further proposes that aggregate production quotas for all other schedules I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.
All interested persons are invited to submit their comments in writing or electronically regarding this proposal following the procedures in the ADDRESSES section of this document. A person may object to or comment on the proposal relating to any of the above-mentioned substances without filing comments or objections regarding the others. If a person believes that one or more of these issues warrant a hearing, the individual should so state and summarize the reasons for this belief. Persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means.
In the event that comments or objections to this proposal raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the Federal Register, summarizing the issues to be heard and setting the time for the hearing as per 21 CFR 1303.13(c).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this action will not have a significant economic impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-612. The establishment of aggregate production quotas for schedules I and II controlled substances is mandated by law and by international treaty obligations. The quotas are necessary to provide for the estimated medical, scientific, research and industrial needs of the United States, for lawful export requirements, and the establishment and maintenance of reserve stocks. While aggregate production quotas are of primary importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis.
Executive Order 12866
The Office of Management and Budget has determined that notices of aggregate production quotas are not subject to centralized review under Executive Order 12866.
Executive Order 13132
This action does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132.
Executive Order 12988
This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Unfunded Mandates Reform Act of 1995
This action will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
Congressional Review Act
This action is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This action will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, Start Printed Page 36515investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
Start SignatureEnd Signature End Supplemental InformationDated: July 16, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-17536 Filed 7-22-09; 8:45 am]
BILLING CODE 4410-09-P
Document Information
- Published:
- 07/23/2009
- Department:
- Drug Enforcement Administration
- Entry Type:
- Notice
- Action:
- Notice of proposed revised 2009 aggregate production quotas.
- Document Number:
- E9-17536
- Dates:
- Written comments must be postmarked, and electronic comments must be sent, on or before August 24, 2009.
- Pages:
- 36511-36515 (5 pages)
- Docket Numbers:
- Docket No. DEA-317R
- PDF File:
- e9-17536.pdf